The following data is part of a premarket notification filed by Maxx Orthopedics, Inc. with the FDA for Libertas E-xlpe Modular Liner.
| Device ID | K192989 |
| 510k Number | K192989 |
| Device Name: | Libertas E-XLPE Modular Liner |
| Classification | Hip, Semi-constrained, Cemented, Metal/ceramic/polymer + Additive, Porous Uncemented |
| Applicant | Maxx Orthopedics, Inc. 2460 General Armistead Ave, Suite 100 Norristown, PA 19403 |
| Contact | Priscilla Herpai |
| Correspondent | Priscilla Herpai Maxx Orthopedics, Inc. 2460 General Armistead Ave, Suite 100 Norristown, PA 19403 |
| Product Code | OQI |
| Subsequent Product Code | LZO |
| Subsequent Product Code | OQG |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-25 |
| Decision Date | 2020-10-29 |